FDA.reportPublic FDA data

Dicyclomine hydrochloride

Product NDC
0054-0748
11-digit product format
000540748
Labeler code
0054
Product ID
0054-0748_99d7d1ce-47b5-4bbd-afe0-908505a9a51b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA040204
Marketing category
ANDA
Marketing start
1997-02-28
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dicyclomine hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICYCLOMINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCQ903KQA31
Rxcui991061

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f755a917-03bc-45af-a1e3-50286868bfdbProduct name920250303
f27796e1-d653-495b-932a-f51768e9be8aProduct name220211021

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0054-0748-25Dicyclomine hydrochloride100 in 1 BOTTLE, PLASTICCAPSULE1001
0054-0748-31Dicyclomine hydrochloride1000 in 1 BOTTLE, PLASTICCAPSULE10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0748-25EA - Each0054-0748aa7cc434-8092-41bb-bb0b-6db4a8b0d17412023-06-06
0054-0748-31EA - Each0054-0748c05c19c9-8efb-43eb-9546-4122d41c8b5512023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-0748DICYCLOMINE HYDROCHLORIDE CAPSULE [HIKMA PHARMACEUTICALS USA INC.]1Current NDC, 2 package rows20230603_99d7d1ce-47b5-4bbd-afe0-908505a9a51b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991061dicyclomine HCl 10 MG Oral CapsulePSNa16e7b6b-dbc9-463d-9bde-dba4f25589cf2
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCDa16e7b6b-dbc9-463d-9bde-dba4f25589cf2
991061dicyclomine HCl 10 MG Oral CapsulePSN01413a77-48f8-1a8a-e063-6394a90ae4941
991061dicyclomine HCl 10 MG Oral CapsulePSN99d7d1ce-47b5-4bbd-afe0-908505a9a51b1
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD01413a77-48f8-1a8a-e063-6394a90ae4941
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD99d7d1ce-47b5-4bbd-afe0-908505a9a51b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0054-0748-2500054074825100 CAPSULE in 1 BOTTLE, PLASTIC (0054-0748-25) 100 capsule2023-06-05NoNoHistorical
0054-0748-31000540748311000 CAPSULE in 1 BOTTLE, PLASTIC (0054-0748-31) 1000 capsule2023-06-05NoNoHistorical